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The drug is intended for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The application has been given a PDUFA target action date of 21 June 2024.

The sBLA is supported by results from the ADHERE study, which assessed the safety and efficacy of subcutaneously administered Vyvgart Hytrulo in adults with CIDP. The study met its primary endpoint, showing a 61% lower risk of relapse when treated with the drug, compared to placebo.

Luc Truyen, chief medical officer of argenx, commented: “Today’s announcement brings us one step closer to delivering the transformative innovation of Vyvgart Hytrulo to CIDP patients. CIDP is yet another example of an autoimmune disease that has not been well understood and for which there has been insufficient innovation for patients. We chose to use a priority review voucher to accelerate review of our submission because CIDP patients have long been waiting for new treatment options. FDA’s acceptance of the sBLA represents an important milestone in our continued drive to bring novel treatments for rare, autoimmune diseases and a significant step forward for people whose lives have been profoundly impacted by this devastating disease.”

According to the company’s press release: ‘Vyvgart Hytrulo was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of Vyvgart. After completing ADHERE, 99% of eligible patients (226/228) continued to the ADHERE-+ open-label extension study’.